Clin Chem Lab Med. 2025 May 5. doi: 10.1515/cclm-2025-0418. Online ahead of print. ABSTRACT Cardiac injury, encompassing a spectrum of heart muscle damage, requires prompt and accurate diagnosis to improve patient outcomes. Early detection using cardiac biomarkers is vital for timely intervention and reducing mortality. This review highlights the role of high-sensitivity cardiac troponins (hs-cTns) … Read more
Clin Chem Lab Med. 2025 May 5. doi: 10.1515/cclm-2025-0490. Online ahead of print. ABSTRACT After the dissemination of a manifesto for the implementation of value-based laboratory medicine (VBLM) and a Strategic Conference dedicated to this issue, a novel initiative of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) is to be initiated with … Read more
Clin Chem Lab Med. 2025 May 5. doi: 10.1515/cclm-2025-0323. Online ahead of print. ABSTRACT Laboratory diagnostics play a crucial role in modern medicine and healthcare economics. The effective management of a medical laboratory is based on reliable assessment of indicators characterizing quality of testing, productivity, velocity (speed) and cost-effectiveness. The usual concepts of laboratory management … Read more
Clin Chem Lab Med. 2025 May 5. doi: 10.1515/cclm-2025-0190. Online ahead of print. ABSTRACT OBJECTIVES: Clinical laboratory errors pose a threat to patient safety and previous studies have demonstrated that pre-analytical error is the most common error type. Our study aimed to determine the types and frequency of errors occurring in clinical laboratory testing in … Read more
Clin Chem Lab Med. 2025 May 1. doi: 10.1515/cclm-2024-1510. Online ahead of print. ABSTRACT OBJECTIVES: In the early stage of gastric cancer (GC), identifying cancer-specific biomarkers is a key step in the disease screening process. This study aims to explore the clinical value of five novel protein biomarkers and their combination (5 MP) for GC … Read more
Clin Chem Lab Med. 2025 May 1. doi: 10.1515/cclm-2025-0352. Online ahead of print. ABSTRACT OBJECTIVES: In serum immunofixation electrophoresis, therapeutic monoclonal antibodies (tmAbs) can be misinterpreted as paraproteins. Strategies to circumvent these interferences include the use of anti-tmAb antibodies, which led to the development of the Hydrashift assay. However, this assay is exclusively available for … Read more
Clin Chem Lab Med. 2025 May 1. doi: 10.1515/cclm-2025-0186. Online ahead of print. ABSTRACT OBJECTIVES: Therapeutic drug monitoring (TDM) is critical for optimizing antipsychotic therapy, yet inter-laboratory comparability in China remains poor. Unstandardized practices risk suboptimal dosing and adverse effects, highlighting the need for standardization. This study evaluated TDM practices for six antipsychotics (olanzapine, clozapine, … Read more
Clin Chem Lab Med. 2025 Apr 28. doi: 10.1515/cclm-2025-0486. Online ahead of print. ABSTRACT The IFCC Task Force on Global Lab Quality (TF-GLQ) has recently released a new guidance for internal quality control (IQC) practice through an approach translating the general principles as stated in the ISO 15189:2022 standard to a series of practical recommendations. … Read more
Clin Chem Lab Med. 2024 Dec 31;63(6):1139-1152. doi: 10.1515/cclm-2024-1350. Print 2025 May 26. ABSTRACT OBJECTIVES: Measurements of acid-base status are performed quickly after blood sampling avoiding errors. This necessitates rapid sample transport which can be problematic. This study measures blood sampled in critically ill patients over 180 min and proposes a mathematical physio-chemical model to … Read more
Clin Chem Lab Med. 2025 Apr 25. doi: 10.1515/cclm-2025-0098. Online ahead of print. ABSTRACT OBJECTIVES: Potential coeliac disease (PCD) is defined by the presence of positive CD-specific autoantibodies with a normal/extremely mildly damaged intestinal mucosa. This study sought to examine the progression of PCD in children maintaining a gluten-containing diet and to identify risk factors … Read more
Clin Chem Lab Med. 2025 Apr 24. doi: 10.1515/cclm-2025-0329. Online ahead of print. ABSTRACT OBJECTIVES: To explore the reasons behind the lack of commutability in protein solution reference materials (RMs) and seeks to eliminate these factors in order to develop commutable reference materials, using human insulin (hINS) as example, to meet the growing demand for … Read more
Clin Chem Lab Med. 2025 Apr 24. doi: 10.1515/cclm-2025-0240. Online ahead of print. ABSTRACT OBJECTIVES: Serum cholinesterase (ChE) 3.1.1.8 is measured to assess exposure to organophosphorus pesticides and determine deficiency related to prolonged apnea after the induction of anesthesia with certain drugs and less often as an indicator of liver function. Biological variation (BV) is … Read more
Clin Chem Lab Med. 2025 Apr 24. doi: 10.1515/cclm-2025-0478. Online ahead of print. ABSTRACT The negative impact of preanalytical errors on the quality of laboratory testing is now universally recognized. Nonetheless, recent technological advancements and organizational transformations in healthcare – catalyzed by the still ongoing coronavirus disease 2019 (COVID-19 pandemic) – have introduced new challenges … Read more
Clin Chem Lab Med. 2025 Apr 21. doi: 10.1515/cclm-2025-0007. Online ahead of print. ABSTRACT OBJECTIVES: To investigate whether renal function impacts CSF κ-FLC concentration and/or κ-FLC index. METHODS: Patients with non-inflammatory neurological diseases were eligible. κ-FLC index was calculated as (CSF κ-FLC/serum κ-FLC)/albumin quotient. Structural equation modeling (SEM) was used to evaluate the direct influence … Read more
Clin Chem Lab Med. 2025 Apr 21. doi: 10.1515/cclm-2025-0128. Online ahead of print. ABSTRACT OBJECTIVES: The diagnostic accuracy of presepsin (P-SEP) in the newborn is still under evaluation. METHODS: In a multicenter study, we studied the accuracy of P-SEP as a diagnostic marker of late-onset sepsis (LOS) in critical newborns with underlying disorders, to define … Read more
Clin Chem Lab Med. 2025 Apr 21. doi: 10.1515/cclm-2025-0089. Online ahead of print. ABSTRACT OBJECTIVES: Accurate medical laboratory reports are essential for delivering high-quality healthcare. Recently, advanced artificial intelligence models, such as those in the ChatGPT series, have shown considerable promise in this domain. This study assessed the performance of specific GPT models-namely, 4o, o1, … Read more
Clin Chem Lab Med. 2025 Apr 18. doi: 10.1515/cclm-2025-0203. Online ahead of print. ABSTRACT OBJECTIVES: Monoclonal gammopathies (MGs) are characterized by the presence of monoclonal immunoglobulins (M-proteins). Currently, recommendations for screening of MGs primarily rely on nephelometry, turbidimetry and electrophoresis, which have inherent limitations in sensitivity and throughput. This study aimed to evaluate a novel … Read more
Clin Chem Lab Med. 2025 Apr 17. doi: 10.1515/cclm-2024-1478. Online ahead of print. ABSTRACT OBJECTIVES: Cortisone is an inert precursor/metabolite of the potent steroid hormone cortisol. Measurement of serum cortisone levels and the cortisol-cortisone ratio can be useful for the diagnosis of dysfunction in the regulation of cortisol levels (i.e., severe and subtle apparent mineralocorticoid … Read more
Clin Chem Lab Med. 2025 Apr 17. doi: 10.1515/cclm-2024-1118. Online ahead of print. ABSTRACT OBJECTIVES: We aimed to evaluate sex-specific 0-h high-sensitivity cardiac troponin T (hs-cTnT) thresholds for risk stratification in patients with suspected non-ST-segment elevation myocardial infarction (NSTEMI). METHODS: This retrospective study investigated a derivation cohort of 6,691 (44.4 % female and aged 65 … Read more
Clin Chem Lab Med. 2025 Apr 16. doi: 10.1515/cclm-2025-0152. Online ahead of print. ABSTRACT Laboratory medicine is faced with rapid developments in data exchange, secondary use of data and artificial intelligence. Safe exchange of laboratory data requires a suitable terminology standard. NPU, LOINC and SNOMED CT are increasingly used for this purpose, but none of … Read more
Clin Chem Lab Med. 2025 Apr 14. doi: 10.1515/cclm-2024-1226. Online ahead of print. ABSTRACT OBJECTIVES: Diagnosing monoclonal gammopathy in chronic kidney disease (CKD) patients is challenging due to the complex interpretation of serum free light chain (FLC) levels. This study aimed to assess the FLC levels in a large cohort of Chinese CKD patients. METHODS: … Read more
Clin Chem Lab Med. 2025 Apr 14. doi: 10.1515/cclm-2025-0183. Online ahead of print. ABSTRACT OBJECTIVES: Dried blood spot (DBS) specimen acceptance guidelines recommend rejecting specimens based on DBS size, often expressed as a diameter. Computer vision methods can estimate DBS size from images obtained from standalone equipment, smartphone cameras or existing laboratory instrumentation. However, no … Read more
Clin Chem Lab Med. 2025 Apr 11. doi: 10.1515/cclm-2025-0331. Online ahead of print. ABSTRACT INTRODUCTION: To analyze the available evidence about the correlation between the presence of detectable amounts of clostebol metabolites in urine and the transdermal or transmucosal contact of clostebol. CONTENT: A systematic review was performed. A systematic search was conducted in PubMed/MEDLINE, … Read more
Clin Chem Lab Med. 2025 Apr 11. doi: 10.1515/cclm-2025-0401. Online ahead of print. ABSTRACT The Joint Committee for Traceability in Laboratory Medicine (JCTLM) database represents a valuable resource for implementing metrological traceability in laboratory medicine. Three main database users can be identified: (a) in vitro diagnostic (IVD) manufacturers, using the database information for meeting ISO … Read more
Clin Chem Lab Med. 2025 Apr 11. doi: 10.1515/cclm-2025-0180. Online ahead of print. ABSTRACT OBJECTIVES: Traditional biomarkers used for sepsis diagnosis have limited sensitivity and specificity and, so far, are not recommended for sepsis diagnosis. We aimed to evaluate diagnostic accuracy of XN-9000® hematology analyzer derived cell population data (CPD) for sepsis. METHODS: We conducted … Read more
Clin Chem Lab Med. 2025 Apr 8. doi: 10.1515/cclm-2025-0219. Online ahead of print. ABSTRACT Amongst the main perspectives when evaluating the results of medical studies are statistical significance (following formal statistical testing) and clinical significance. While statistical significance shows that a factor’s observed effect on the study results is unlikely (for a given alpha) to … Read more
Clin Chem Lab Med. 2025 Apr 8. doi: 10.1515/cclm-2024-1374. Online ahead of print. ABSTRACT OBJECTIVES: Urine albumin is a key biomarker utilized for diagnosis and monitoring progression of chronic kidney disease (CKD). These characteristics highlight the importance urine albumin serves in patient management. However, laboratory results are confounded by a lack of standardization where results … Read more
Clin Chem Lab Med. 2025 Apr 8. doi: 10.1515/cclm-2025-0264. Online ahead of print. ABSTRACT OBJECTIVES: Macroprolactin (macro-PRL) mostly comprises a complex of PRL with IgG. The aim of this study was to clarify whether IgA-type macro-PRL exists and, if so, to elucidate the prevalence of and differences in laboratory data from IgG-type. METHODS: One hundred … Read more
Clin Chem Lab Med. 2025 Apr 7. doi: 10.1515/cclm-2025-0177. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to investigate the prevalence of macroprolactinemia and the changes in hyperprolactinemia status over time among hyperprolactinemic patients in the Turkish population. METHODS: A retrospective study was conducted on 3,013 patient records from a central university hospital between … Read more
Clin Chem Lab Med. 2025 Apr 7. doi: 10.1515/cclm-2024-1312. Online ahead of print. ABSTRACT OBJECTIVES: Primary aldosteronism (PA) is a common cause of secondary hypertension. The aldosterone-to-renin ratio (ARR) is the current recommended biomarker for PA screening, but it has limitations. This study evaluates another ratio, the aldosterone-to-angiotensin II ratio (AAIIR), as an alternative screening … Read more
Clin Chem Lab Med. 2025 Apr 4. doi: 10.1515/cclm-2025-0163. Online ahead of print. ABSTRACT OBJECTIVES: Recent advances in information technology have renewed interest in patient-based real-time quality control (PBRTQC) as an alternative to internal quality control (IQC). However, since regulations mandate IQC, PBRTQC can only be implemented as a separate system. The additional labor required … Read more
Clin Chem Lab Med. 2025 Mar 31. doi: 10.1515/cclm-2025-0117. Online ahead of print. ABSTRACT OBJECTIVES: The stability of plasma samples for basic coagulation tests, prothrombin time (PT) and activated partial thromboplastin time (aPTT), has been widely studied. Recently, the Clinical and Laboratory Standards Institute (CLSI) updated its recommendations, extending the acceptable time frame for aPTT. … Read more
Clin Chem Lab Med. 2025 Mar 25. doi: 10.1515/cclm-2024-1387. Online ahead of print. ABSTRACT OBJECTIVES: We determined the efficacy of a high sensitivity cardiac troponin I (hs-cTnI) assay for newly derived 0 h and 0/2-h rule-out concentrations for myocardial infarction and determined the safety of incremental changes at low concentrations. METHODS: Consecutive, emergency department patients … Read more
Clin Chem Lab Med. 2025 Mar 24. doi: 10.1515/cclm-2024-1428. Online ahead of print. ABSTRACT OBJECTIVES: The insulin-like growth factors (IGFs) regulate growth in humans. IGF-I and IGF binding protein (IGFBP)-3 are biomarkers in children with growth disorders. We investigate a targeted proteomics method for absolute quantitation of eight IGF protein family members in human serum, … Read more
Clin Chem Lab Med. 2025 Mar 21. doi: 10.1515/cclm-2025-0032. Online ahead of print. ABSTRACT OBJECTIVES: The Certified Reference Material (CRM) ERM®-DA477/IFCC is a new polyclonal IgG anti-beta2-glycoprotein I (anti-β2GPI) material for the harmonization of the laboratory diagnosis of antiphospholipid syndrome (APS). We evaluated CRM’s ability to represent the heterogeneity of APS patient anti-β2GPI antibodies and … Read more
Clin Chem Lab Med. 2025 Mar 20. doi: 10.1515/cclm-2024-1400. Online ahead of print. ABSTRACT OBJECTIVES: Many patients with sex chromosome abnormalities (SCAs) are diagnosed late in life or remain undiagnosed, leading to delayed or inadequate medical intervention and care. This study aimed to develop a reliable, rapid and cost-effective test for identifying SCAs using a … Read more
Clin Chem Lab Med. 2025 Mar 20. doi: 10.1515/cclm-2024-1399. Online ahead of print. ABSTRACT OBJECTIVES: Medical biology is essential for diagnosing and monitoring cardio-reno-metabolic diseases. The EPI-CKD1 study utilizes data from Biogroup® French laboratories to examine the burden of chronic kidney disease (CKD) and the effect of heart failure, and diabetes in an outpatient setting … Read more
Clin Chem Lab Med. 2025 Mar 19. doi: 10.1515/cclm-2024-1360. Online ahead of print. ABSTRACT OBJECTIVES: Human tear analysis holds promise for biomarker discovery, but its clinical utility is hindered by the lack of standardized reference values, limiting interindividual comparisons. This study aimed at developing a protocol for normalizing metabolomic data from human tears, enhancing its … Read more
Clin Chem Lab Med. 2025 Mar 17. doi: 10.1515/cclm-2024-0962. Online ahead of print. ABSTRACT OBJECTIVES: Detecting point mutations with high sensitivity and specificity can be technically very challenging, but it is crucial for early diagnosis and effective drug treatment of cancers. To enable ultrasensitive and ultraspecific detection of single-base mutations in simple and economical ways, … Read more
Clin Chem Lab Med. 2025 Mar 17. doi: 10.1515/cclm-2025-0115. Online ahead of print. ABSTRACT OBJECTIVES: In patients with chronic lymphocytic leukemia (CLL), the white progenitor cell (WPC) channel of the Sysmex XN hematology analyzers typically shows a varying proportion of cells in the upper left field of the scattergram, resembling the shape of shark fins. … Read more
Clin Chem Lab Med. 2025 Mar 14. doi: 10.1515/cclm-2025-0109. Online ahead of print. ABSTRACT OBJECTIVES: Evaluate the stability of 32 biochemical analytes in venous blood samples stored at 18-25 °C under different time delays prior to centrifugation. METHODS: A prospective study was conducted involving 33 healthy volunteers. Four venous blood samples were collected from each … Read more
Clin Chem Lab Med. 2025 Mar 6. doi: 10.1515/cclm-2024-1139. Online ahead of print. ABSTRACT OBJECTIVES: Isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC MS/MS)-based candidate reference measurement procedures (RMPs) for the quantification of 24,25(OH)2D2 and 24,25(OH)2D3 in human serum and plasma are presented. METHODS: Quantitative nuclear magnetic resonance (qNMR) spectroscopic methodology was utilized to assign absolute content … Read more
Clin Chem Lab Med. 2025 Mar 10. doi: 10.1515/cclm-2024-1246. Online ahead of print. ABSTRACT OBJECTIVES: To improve the accuracy of lymphocyte subsets counts, a traceable dual-platform extended PanLeucogating method (DPP) of absolute cell counts of lymphocyte subsets was introduced, and consistency was evaluated by comparing conventional single/dual-platform method with DPP. METHODS: The DPP for absolute … Read more
Clin Chem Lab Med. 2025 Mar 12. doi: 10.1515/cclm-2024-1237. Online ahead of print. ABSTRACT OBJECTIVES: To compare clinical laboratory workflows for the assessment of androgens in men, focusing on total testosterone (T), sex hormone-binding globulin (SHBG) and free T, in clinical laboratories throughout Europe. METHODS: An internet-based survey that included questions related to pre-analytical, analytical … Read more
Clin Chem Lab Med. 2025 Mar 13. doi: 10.1515/cclm-2024-1476. Online ahead of print. ABSTRACT OBJECTIVES: The Apollo study was designed to support the clinical performance verification of the adjusted cutoffs of the Elecsys® β-Amyloid(1-42) (Aβ42) cerebrospinal fluid (CSF) II, β-Amyloid(1-40) (Aβ40) CSF, Phospho-Tau (181P) (pTau) CSF and Total-Tau (tTau) CSF immunoassays (Roche Diagnostics International Ltd) … Read more
Clin Chem Lab Med. 2025 Mar 13. doi: 10.1515/cclm-2024-1503. Online ahead of print. ABSTRACT OBJECTIVES: Risk-based stratification approaches using measurable residual disease (MRD) successfully help to identify T-acute lymphoblastic leukemia (T-ALL) patients at risk of relapse, whose treatment outcomes are very poor. Because of T-ALL heterogeneity and rarity, a reliable and standardized approach for flow … Read more
Clin Chem Lab Med. 2025 Mar 11. doi: 10.1515/cclm-2024-1193. Online ahead of print. ABSTRACT R language has gained traction in laboratory medicine for its statistical power and dynamic tools like RMarkdown and RShiny. However, there is limited literature summarizing R packages and functions tailored for laboratory medicine, making it difficult for clinical laboratory workers to … Read more
Clin Chem Lab Med. 2025 Mar 11. doi: 10.1515/cclm-2025-0093. Online ahead of print. ABSTRACT OBJECTIVES: To establish the reference intervals (RIs) of serum glial fibrillary acid protein (GFAP) measured by the fully automated Lumipulse system. METHODS: The study population consisted of 340 healthy individuals, including 251 blood donors and 89 outpatients, with a median age … Read more
Clin Chem Lab Med. 2025 Mar 10. doi: 10.1515/cclm-2024-1457. Online ahead of print. ABSTRACT OBJECTIVES: The identification of reliable quality indicators (QIs) in the total testing process (TTP) is a pivotal step in quantifying laboratory service quality. This study comprehensively evaluated the performance quality and explored the factors affecting laboratory quality in Guangdong Province, China, … Read more
